Eli Lilly and Company
REMS Programs place undue burden on clinicians
Submitted by Anonymous on Sat, 2010-02-20 00:25- Clinical research
- Congress
- counseling
- director
- Eli Lilly and Company
- FDA
- Food and Drug Administration
- forward
- Health
- Health
- John Jenkins
- John K. Jenkins
- Labor
- Labor
- M.D.
- Maryland
- Medicine
- Methadone
- Michael Benjamin
- model for drug approvals
- Natalizumab
- Opioid
- Person Career
- Pharmaceutical industry
- Pharmaceutical sciences
- Pharmaceuticals policy
- Pharmacology
- physician
- Revlimid
- Social Issues
- Social Issues
- Terry Toigo
- Thalomid
- Tysabri
- Velcade
Dr. Jenkins--
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list.
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FDA sets decision date for Zevalin in lymphoma consolidation
Submitted by Anonymous on Mon, 2009-07-20 09:00Consolidation. Never thought the word could be sexy but as a concept it's huge in oncology right now. The concept is this: after the patient is finished with initial chemo they move on to chemo "lite" to consolidate the gains they made with initial treatment. The vexing problem of lymphoma and a few other cancers is this: we can usually induce a remission but the disease often comes back and is much harder to treat when it does. So the strategy is becoming: find a treatment that will prolong the remission if not make it permanent.
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Alimta shows consolidation survival advantage
Submitted by Anonymous on Sat, 2009-05-30 22:14Ongoing research was presented today at ASCO: Alimta consolidation chemotherapy improves survival in lung cancer patients. This was presented as an abstract last year (outcome reported back then was improved progression free survival) and makes a return visit this year with a survival story. A base hit turns into a triple: there have not been that many therapies that prolong survival in lung cancer. The benefit was three months more survival though these numbers got used against us in the Avastin setting so let's just call it a clinically meaningful improvement in survival.
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Further data on Alimta (pemetrexed) in ovarian cancer
Submitted by Anonymous on Tue, 2009-04-07 23:17Some successes reported in small study. This goes along with other research that has been previously published. I am a little disappointed that the numbers are not better but perhaps this indicates there is a role for Alimta in earlier lines of treatment for this disease. I have had a great string of success using Alimta in the "consolidation" phase of lung cancer treatment lately; perhaps this will be its role in ovarian cancer treatment as well? Thanks again to H*O*P*E for a nice post. http://healthinfoispower.wordpress.com/2009/04/07/gog-reports-on-evaluat...
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New Byetta data looks good according to press release
Submitted by Anonymous on Mon, 2009-04-06 20:49This is one of those press release announcements made completely independent of any journal article or conference presentation so take it for what it's worth but still the information was compelling: Byetta controls diabetes better than sitagliptin and pioglitazone. The clinical trial details are available on Pipelinereview.com which is a great site or is that just me? http://www.pipelinereview.com/content/view/26156/114/ Basically the injectable exenatide reduced HbA1c better than the oral meds and led to impressive weight loss.
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Intensive insulin control worsens mortality in the ICU
Submitted by Anonymous on Wed, 2009-03-25 23:19This contradicts prior studies showing a benefit to strict glucose control in the ICU
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Company grows insulin in plants
Submitted by Anonymous on Thu, 2009-03-19 22:20Getting closer to an FDA approval a company demonstrates "bioequivalence" of their new plant-derived insulin versus conventional recombinant insulin. http://www.pipelinereview.com/content/view/25803/114/
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Cinammon for diabetes?
Submitted by Anonymous on Thu, 2009-03-19 20:53Thanks for the question Ed Kearney. Looks like this idea is in the category of "inconsistent data probable biological plausibility not ready for prime time." 2008 study showed no lipid or glucose benefit in diabetic patients. Helpful to improve insulin resistance in mice 2008. Improvement in insulin sensitivity in healthy individuals. No effect in a randomized clinical trial of 60 diabetics 2007. Improvements in glucose and lipids seen in 60 less-ill diabetics 2003. Overall impression: the data are not very strong but it looks like there is some sort of biological effect.
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Alimta approved for first line treatment of lung cancer
Submitted by Anonymous on Mon, 2008-09-29 15:21Alimta approved for first line treatment of lung cancer
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Insulin pill enters clinical testing
Submitted by Anonymous on Sat, 2008-09-27 23:30Insulin pill enters clinical testing
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